Magnetic compression anastomosis device with multipiece vertebra

ABSTRACT

A magnetic compression anastomosis device comprises a plurality of interconnected vertebrae including a first vertebra and a second vertebra, wherein each of the first vertebra and the second vertebra is a multipiece vertebra comprising a magnet at least partially encapsulated by a vertebra skin, and wherein the first vertebra and the second vertebra are interconnected by a cylindrical roller and at least one flex element, the roller and the at least one flex element at least partially encapsulated by the first vertebra skin and the second vertebra skin, the roller configured to allow the first and second vertebra to pivot through a predetermined range of rotation in a device plane between at least a delivery configuration and an assembled configuration while constraining movement in other degrees of freedom, the at least one flex element biasing the first and second vertebra toward the assembled configuration.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This patent application claims the benefit of U.S. Provisional PatentApplication No. 63/395,570 entitled SUPPORT FOR MAGNETIC SEGMENTS OF AMAGNETIC ANASTOMOSIS DEVICE filed Aug. 5, 2022, which is herebyincorporated herein by reference in its entirety.

FIELD OF INVENTION

The invention relates to deployable magnetic compression devices, and,more particularly, to systems, devices, and methods for the delivery,deployment, and positioning of magnetic compression devices at a desiredsite so as to improve the accuracy of anastomoses creation betweentissues, organs, or the like.

BACKGROUND

Bypasses of the gastroenterological (GI), cardiovascular, or urologicalsystems are typically formed by cutting holes in tissues at twolocations and joining the holes with sutures or staples. A bypass istypically placed to route fluids (e.g., blood, nutrients) betweenhealthier portions of the system, while bypassing diseases ormalfunctioning tissues. The procedure is typically invasive, andsubjects a patient to risks such as bleeding, infection, pain, andadverse reaction to anesthesia. Additionally, a bypass created withsutures or staples can be complicated by post-operative leaks andadhesions. Leaks may result in infection or sepsis, while adhesions canresult in complications such as bowel strangulation and obstruction.While traditional bypass procedures can be completed with an endoscope,laparoscope, or robot, it can be time consuming to join the holes cutinto the tissues. Furthermore, such procedures require specializedexpertise and equipment that is not available at many surgicalfacilities.

As an alternative to sutures or staples, surgeons can use mechanicalcouplings or magnets to create a compressive anastomosis betweentissues. For example, compressive couplings or paired magnets can bedelivered to tissues to be joined. Because of the strong compression,the tissue trapped between the couplings or magnets is cut off from itsblood supply. Under these conditions, the tissue becomes necrotic anddegenerates, and at the same time, new tissue grows around points ofcompression, e.g., on the edges of the coupling. With time, the couplingcan be removed, leaving a healed anastomosis between the tissues.

Nonetheless, the difficulty of placing the magnets or couplings limitsthe locations that compressive anastomosis can be used. In most cases,the magnets or couplings have to be delivered as two separateassemblies, requiring either an open surgical field or a bulky deliverydevice. For example, existing magnetic compression devices are limitedto structures small enough to be deployed with a delivery conduit e.g.,an endoscopic instrument channel or laparoscopic port. When thesesmaller structures are used, the formed anastomosis is small and suffersfrom short-term patency. Furthermore, placement of the magnets orcouplings can be imprecise, which can lead to anastomosis formation inlocations that is undesirable or inaccurate.

Thus, there still remains a clinical need for reliable devices andminimally-invasive procedures that facilitate compression anastomosisformation between tissues in the human body.

SUMMARY

During the deployment of a self-forming magnetic array, control of theindividual magnetic pieces is critical. Limiting the degrees of freedomto a specific set of parameters provides durability as well as improvedgeometric shape control. When connecting two separate magnets it is alsoimportant that the geometric shapes align to produce a compressionregion with high enough pressure to shut down fluidic exchange to thetissue in the inner periphery of the geometric shape created by theself-forming array.

An embodiment of the present invention utilizes independent magnetsconnected by a multipiece vertebrae design. Prior innovations utilize asingle formed piece of alloy to create the support. The presentinvention utilizes individual flex segments which connect to flexingarmatures, a vertebrae casing, and either a “roller” or an integrated“rolling node” to limit degrees of freedom during formation and increasedurability.

During coupling of two magnetic arrays, the ability to sense the matingarray is more easily done with a single magnetic pole face. Anembodiment of the invention provides for an internal skeleton thatforces the same pole faces together.

More particularly, in accordance with one embodiment of the invention, amagnetic compression anastomosis device comprises a plurality ofinterconnected vertebrae including a first vertebra and a secondvertebra, wherein each of the first vertebra and the second vertebra isa multipiece vertebra comprising a magnet at least partiallyencapsulated by a vertebra skin, and wherein the first vertebra and thesecond vertebra are interconnected by a cylindrical roller and at leastone flex element, the roller and the at least one flex element at leastpartially encapsulated by the first vertebra skin and the secondvertebra skin, the roller configured to allow the first and secondvertebra to pivot through a predetermined range of rotation in a deviceplane between at least a delivery configuration and an assembledconfiguration while constraining movement in other degrees of freedom,the at least one flex element biasing the first and second vertebratoward the assembled configuration.

In various alternative embodiments, the vertebra skin may include atleast one of a metal alloy, a polymer, or a composite material, e.g., ashape memory material. The vertebra skin may be configured with varioustypes of features such as at least one tissue cutting element, at leastone tissue compression element, and/or tissue securing element. Eachvertebra skin may include male nodes and female nodes at opposing endsof the vertebra skin, in which case the male nodes may be configured tosecure the roller in place. The roller may be, for example, a hollowcylinder or a solid cylinder. The flex element may include a flexiblebar (e.g., including a spring mechanism such as a shape memory material)or a pair of U-brackets operationally coupled to the roller. In someembodiments, the roller and the flex element may be implemented using acoil or torsion spring. The vertebrae may be aligned in a substantiallylinear arrangement in the delivery configuration and/or may be arrangedin a circular or polygon arrangement in the assembled configuration. Thevertebrae may include a proximal end vertebra and a distal end vertebrathat magnetically couple to one another in the assembled configuration.

In accordance with another embodiment of the invention, a magneticcompression anastomosis system comprises a delivery device comprising alumen and at least one magnetic compression anastomosis device asdescribed above, predisposed within the lumen of the delivery device inthe delivery configuration.

Additional embodiments may be disclosed and claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

Those skilled in the art should more fully appreciate advantages ofvarious embodiments of the invention from the following “Description ofIllustrative Embodiments,” discussed with reference to the drawingssummarized immediately below.

FIG. 1 shows a magnet assembly delivered through an endoscope instrumentchannel such that the individual magnets self-assemble into a largermagnetic structure--in this particular case, an octagon.

FIG. 2A shows magnet assemblies that have been delivered and deployed toadjacent tissues.

FIG. 2B shows the two magnet assemblies coupled together by magneticattraction, capturing the intervening tissue. In some instances, theendoscope can be used to cut through the circumscribed tissue.

FIG. 3 shows several potential anatomical targets for anastomosisformation: Arrow A is stomach to small intestine, Arrow B is smallintestine to large intestine, Arrow C is small intestine to smallintestine, Arrow D is large intestine to large intestine, and Arrow E isstomach to large intestine.

FIG. 4A shows one embodiment of delivery using two endoscopes(colonoscope and enteroscope or gastroscope) to deliver magnetassemblies.

FIG. 4B shows another embodiment of delivery using two upper endoscopesboth sharing per-oral entry to deliver magnet assemblies.

FIG. 5 shows another embodiment of delivery using a single endoscope tosequentially deliver magnet assemblies.

FIG. 6 shows another embodiment of delivery using endoscopic ultrasoundguided needle delivery of one magnet assembly into lumen #1 followed bydeployment to of the second magnet assembly in lumen #2.

FIG. 7 shows the creation of a preliminary anastomosis to serve as aconduit for deeper endoscope delivery in order to create subsequentmultiple anastomoses.

FIG. 8 shows laparoscopic magnet device delivery into a lumen (stomach,in this example).

FIG. 9A shows endoscopic ultrasound guided needle delivery of a magnetassembly into the gallbladder which then couples with a second magnetassembly in the stomach or duodenum as shown in FIG. 9B.

FIG. 10 shows stent deployment between the gallbladder and either thestomach or duodenum.

FIG. 11 shows another embodiment of an intra-gallbladder magnet assemblythat is a balloon that fills with fluid, gas, or magnetic material. Thisballoon is tethered to the endoscope and is initially delivered throughan endoscopic ultrasound guided needle.

FIG. 12 shows endoscopic ultrasound guided needle delivery of a magnetassembly into the bile duct.

FIG. 13 shows magnet assembly delivery into the bile duct throughendoscopic retrograde cholangiopancreatography techniques.

FIG. 14 shows coupling of the intra-bile duct magnet assembly with asecond magnet assembly deployed either in the stomach (A) or duodenum(B).

FIG. 15 shows another embodiment of bile duct magnetic anastomosis inwhich a hinged magnetic bile duct stent swings back onto itself bymagnetic attraction to form an anastomosis between the bile duct andduodenum.

FIG. 16 shows a magnetic stent that can be delivered into the pancreaticduct. The stent can be coupled with a magnet in the stomach (A) or inthe duodenum (B) to create a drainage anastomosis for the pancreaticduct.

FIG. 17 shows a magnetic assembly that is delivered into aperipancreatic collection (dotted structure) using endoscopic ultrasoundguided needle/catheter delivery which then couples with a second magnetassembly deployed in the stomach.

FIG. 18 shows different targets for anastomoses between the urinarysystem and the gastrointestinal system: renal calyx (A), ureter (B), andbladder (C).

FIG. 19 shows magnet assemblies in adjacent blood vessels to couple andcreate a vascular anastomosis.

FIG. 20 shows magnet assemblies in different parts of the respiratorysystem to create anastomoses between adjacent bronchioles.

FIG. 21 shows an external magnet assembly and an internal magnetassembly within the gastrointestinal tract used to create a surgicalstoma for fecal drainage.

FIG. 22 depicts an exploded view of multipiece vertebrae of aself-assembling magnetic compression anastomosis device in accordancecertain embodiments.

FIG. 23 is an enlarged view of the various components shown in FIG. 22and also showing an example of a flex element in accordance with certainembodiments.

FIG. 24 shows an alternative example of a flex element in accordancewith certain embodiments.

FIG. 25 shows profiles of various geometries of magnetic segments inaccordance with certain embodiments.

FIG. 26 shows an example of a roller in the form of a torsion spring inaccordance with certain embodiments.

It should be noted that the foregoing figures and the elements depictedtherein are not necessarily drawn to consistent scale or to any scale.Unless the context otherwise suggests, like elements are indicated bylike numerals. The drawings are primarily for illustrative purposes andare not intended to limit the scope of the inventive subject matterdescribed herein.

DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Exemplary embodiments provide improved devices and techniques forminimally invasive formation of anastomoses within the body, e.g., thegastrointestinal tract. Such devices and techniques facilitate fasterand less-expensive treatments for chronic diseases such as obesity anddiabetes. Such techniques also reduce the time and pain associated withpalliative treatments for diseases such as cancers, such as stomach orcolon cancer.

The system generally includes an access device configured to be providedwithin a hollow body of a patient and assist in the formation of ananastomosis at a target site (a desired anatomical location) within thehollow body for formation of an anastomosis between a first portion oftissue of the hollow body at the target site and a second portion oftissue of an adjacent hollow body, e.g., between the gallbladder and thestomach, between the stomach and the duodenum, between the ileum and thecolon, etc. The access device is configured to provide access to thefirst portion of tissue of the hollow body and further deliver andposition a first implantable magnetic anastomosis device. A secondimplantable magnetic anastomosis device is delivered to the adjacenthollow body, e.g., using the same access device or a second accessdevice. The first and second implantable magnetic anastomosis devicesare configured to be magnetically attracted to one another through adefined tissue area of the combined thickness of a wall of the tissuesat the target site and exert compressive forces on the defined area toform the anastomosis.

The systems, devices, and methods described herein include, but are notlimited to, various access devices for accessing a hollow body of thepatient, such as a gall bladder, and securing positioning of the accessdevice for the subsequent placement of one of a pair of magneticanastomosis compression devices. The systems, devices, and methodsdescribed herein further include various delivery devices for deliveringat least one of the pair of magnetic anastomosis compression devices tothe target site, wherein, in some instances, a delivery deviceconsistent with the present disclosure may assist in the deployment ofat least one of the pair of magnetic anastomosis compression devices andsubsequent securing to the target site and/or coupling the pair ofmagnetic anastomosis compression devices to one another. The systems,devices, and methods described herein include various embodiments ofmagnetic anastomosis compression devices and various designs fortransitioning from a compact delivery configuration to a larger deployedconfiguration, generally by way of self-assembling design.

More specifically, exemplary embodiments provide a system including adelivery device for introducing and delivering, via a minimally invasivetechnique, a pair of magnetic assemblies between adjacent organs tobridge walls of tissue of each organ together to thereby form a passagetherebetween (i.e., an anastomosis). The delivery device is particularlyuseful in delivering the pair of magnetic assemblies to a target sitewithin the gastrointestinal tract to thereby form anastomosis betweengastric and gall bladder walls to provide adequate drainage from thegallbladder when blockage is occurring (due to disease or otherhealth-related issues). Accordingly, exemplary embodiments provideimproved devices and techniques for minimally invasive formation ofanastomoses within the body, e.g., the gastrointestinal tract. Suchdevices and techniques facilitate faster and less-expensive treatmentsfor chronic diseases such as obesity and diabetes. Such techniques alsoreduce the time and pain associated with palliative treatments fordiseases such as cancers, such as stomach or colon cancer.

In an endoscopic procedure, for example, the self-assembling magneticdevices can be delivered using a single endoscope. Exemplary magneticanastomosis devices may be delivered through an endoscope such thatindividual magnet segments self-assemble into a larger magneticstructure. When used with the techniques described herein, the devicesallow for the delivery of a larger magnetic structures than wouldotherwise be possible via a small delivery conduit, such as in astandard endoscope, if the devices were deployed as a completedassembly. Larger magnet structures, in turn, allow for the creation oflarger anastomoses that are more robust, and achieve greater surgicalsuccess. For example, in some cases, resulting anastomosis may have a1:1 aspect ratio relative to the final dimensions of the assembledmagnetic devices. However, exemplary embodiments allow for larger aspectratios (i.e., a larger anastomosis to form relative to the dimensions ofthe magnetic assemblies). In particular, prior art systems and methodsthat include the use of magnets for creating anastomosis are generallylimited based on the dimensions of the working channel of the scope orcatheter used for delivering such magnets, which, in turn, limits theresulting size of the anastomosis. However, the magnetic assembly designof exemplary embodiments overcome such limitations. For example, thedesign of the magnetic assembly, notably the coupling of multiplemagnetic segments to one another via a support, allow for any number ofsegments to be included in a single assembly, and thus the resultinganastomosis has a greater size relative to the dimensions of the workingchannel of the scope. For example, in some embodiments, the resultinganastomosis may include an aspect ratio in the range of 2:1 to 10:1 orgreater.

The magnetic anastomosis devices generally comprise magnetic segmentsthat can assume a delivery conformation and a deployed configuration.The delivery configuration is typically linear so that the device can bedelivered to a tissue via a laparoscopic “keyhole” incision or withdelivery via a natural pathway, e.g., via the esophagus, with anendoscope or similar device. Additionally, the delivery conformation istypically somewhat flexible so that the device can be guided throughvarious curves in the body. Once the device is delivered, the devicewill assume a deployed configuration of the desired shape and size byconverting from the delivery configuration to the deployed configurationautomatically. The self-conversion from the delivery configuration tothe deployment configuration is directed by coupling structures thatcause the magnetic segments to move in the desired way withoutintervention. Exemplary self-assembling magnetic anastomosis devices,such as self-closing, self-opening, and the like, are described in U.S.Pat. Nos. 8,870,898, 8,870,899, 9,763,664, and 10,182,821, the contentsof each of which are incorporated by reference herein in their entirety.

During the deployment of a self-forming magnetic array, control of theindividual magnetic pieces is critical. Limiting the degrees of freedomto a specific set of parameters provides durability as well as improvedgeometric shape control. When connecting two separate magnets, it isalso important that the geometric shapes align to produce a compressionregion with high enough pressure to shut down fluidic exchange to thetissue in the inner periphery of the geometric shape created by theself-forming array.

In certain embodiments as depicted schematically in FIG. 22 , a magneticcompression anastomosis device 100 includes multiple magnetic segments101 (three magnetic segments 101 out of eight magnetic segments 101 ofthis embodiment are labeled, although it should be noted thatembodiments are not limited to any particular number of magneticsegments). For convenience, the magnetic segments 101 may be referred toherein as vertebrae 101, and each individual magnetic segment 101 may bereferred to as a vertebra 101.

The vertebrae 101 are configured to allow for movement between adelivery configuration of the device 100 (which is typically with thevertebrae 101 aligned substantially linearly to fit within a deliverydevice such as a catheter, endoscope, laparoscope, trocar, needle, orother delivery device) and a fully assembled configuration of the device100 (e.g., a circular or polygon configuration) while restrictingunwanted degrees of freedom such as twisting, over-rotation,under-rotation, and out-of-plane deflection of one or more vertebra thatcould cause incomplete assembly or non-assembly of the device 100. Thus,embodiments of the device 100 can be self-assembling devices (e.g.,automatically and autonomously transitioning into the fully assembledconfiguration upon delivery) although embodiments additionally oralternatively can include additional elements to assist with or manuallyplace the device 100 into the fully assembled form (e.g., sutures,wires, etc.). For purposes of this discussion, the plane of the device100 can be considered the plane running through the centers of thevertebrae when in the fully assembled configuration. The vertebrae 1010include a proximal end vertebra and a distal end vertebra thatmagnetically couple to one another in the assembled configuration suchas to form a circular or polygon arrangement.

As discussed in greater detail below, in certain embodiments, eachvertebra 101 may be a multipiece vertebra including a vertebra skin 102that fully or partially encapsulates one or more magnets 103 and othercomponents discussed herein. The device 100 can be configured withdifferent magnetic polarity configurations, e.g., all vertebrae 101having the same magnetic polarity, vertebrae 101 with alternatingmagnetic polarities, vertebrae 101 with alternating pairs of magneticpolarities, vertebrae 101, etc. The present invention is not limited toany particular magnetic polarity configurations.

Each pair of adjacent interconnected vertebra 101 is rotatably connectedby a cylindrical roller 104. For purposes of this discussion, acylindrical roller is generally a hollow cylinder (e.g., tubular)although in some embodiments can be a solid cylinder. The roller 104 maybe used to provide radial constraint and limit the degrees of freedomthus strengthening the assembly from a torsional standpoint. The roller104 may be composed of a metal alloy, polymer, and/or composite. Theroller 104 is preferably configured to allow rotation of the vertebrae101 in the device plane, but otherwise to limit other degrees offreedom. The roller 104 may include features such as protrusions orrecesses to help secure the roller 104 in between the two vertebra 101and/or to control the amount of rotation that can occur between the twovertebra 101, e.g., to provide radial constraint and limit the degreesof freedom thus strengthening the assembly from a torsional standpoint.The roller 104 may be composed of any appropriate material such as ametal alloy, polymer, and/or composite. The roller 104 may be a separatecomponent, adapted to fit between two or more magnets 103. Each magnet103 may include a notch on each end adapted to fit a roller allowing formotion in one plane while restricting motion in the plane 90 degreesopposing.

Each pair of adjacent interconnected vertebra 101 typically alsoincludes a flex element 106 (an example of which is shown in FIG. 23 )that helps to move the vertebrae 101 from the delivery configuration tothe assembled configuration. For example, the flex element 106 mayoperate as a spring (e.g., the flex element may include a spring or maybe formed from a shape memory material) and may impose a bias toward theassembled configuration so that the vertebrae 101 are biased toward theassembled configuration upon delivery of the device 100. The flexelement 106 may be composed of any appropriate material, e.g., a metalalloy, polymer, and/or composite and in particular a shape memorymaterial. In various embodiments, the flex segment is positioned betweentwo vertebrae skins on the outside perimeter of the array. It should benoted, however, that the flex segment may also be positioned on theinternal perimeter of the array. The flex segment serves to strengthenthe array as well as limit degrees of freedom. The flex member may alsoserve to aid the array to deploy into the proper assembled geometry.

The vertebra skin 102 may be formed of an appropriate material such asmetal alloy, polymer, and/or composite and in particular may be formedof or include a shape memory material. The vertebra skin 102encapsulates the magnet(s) 103 and helps to secure the roller 104 andflex element 106 within the device 100, forming a protective layer whilealso restricting degrees of freedom. The vertebra skin 102 may besecured onto the magnet(s) 103 with or without additional fasteners suchas screws, pins, adhesive, interlocking elements, etc. Thus, forexample, with a magnet 103, a roller 104, and a flex element 106positioned for assembly, a vertebra skin 102 can be installed over themagnet 103, the roller 104, and the flex element 106 such as toencapsulate the components. As shown, the vertebra skin 102 mayincorporate male nodes 108 and female nodes 110 on opposing ends of thevertebra capable of interacting with the opposing gender node on anothervertebra. The male node 108 of one segment meshes or joins with thefemale node 110 of another segment. The incorporated nodes support themovement in one plane while restricting other degrees of freedom. Themale nodes 108 may assist with securing the roller 104 and/or the flexelement 106 within the device 100. The incorporated nodes may includestops to limit additional degrees of freedom, e.g., to prevent“backwards bending” or excess “forward bending” of the array, asrepresented in view 112. Stops can provide interference of the vertebraewhile allowing a prescribed amount of rotation around the axis of themale and female node interaction.

FIG. 23 is an enlarged view of the various components shown in FIG. 22and also shows an example of a flex element 106, which, in this example,is in the form of a bar having a central spring section, e.g., formed ofa shape memory material. Without limitation, the flex element 106 can beconfigured to fit within channels 114 of the magnets 103 or in any otherconfiguration (e.g., over or under the roller 104, which may include aflex element support 105 on which the flex element 106 rests to providea fulcrum for the flex element 106) allowing the flex element 106 tocontrol the movement of the vertebrae 101 such as biasing the vertebrae101 toward the assembled configuration. Embodiments can include one,two, or more flex elements 106 and related elements such as elements 105and 114, e.g., a flex element 106 placed on both sides of the vertebrae101. A flex element 106 may be a unitary device or may include multiplecomponents.

FIG. 24 shows an alternative example of a flex element 106, which, inthis example, includes two oppositely-oriented U-brackets that, togetherwith the roller 104 and magnets 103 as depicted in view 116, operate asbiased springs in a manner similar to the flex element 106 shown anddescribed above with reference to FIG. 23 . Specifically, a U-bracketmay be placed on each end of a magnetic segment. The U-brackets hold theroller 104 in place while allowing for rotation in one plane butrestricting out-of-plane motion. The U-brackets may be composed of anyappropriate material, e.g., a metal alloy, polymer, and/or composite andin particular may be formed of or include a shape memory material. TheU-brackets allow for movement in a plane while restricting torsionalmotion and motion in the plane 90 degrees opposing. The roller andU-brackets may fit directly on the magnetic segments, and within thevertebrae skins, e.g., the U-brackets may fit through and be secured bythe roller 104, as depicted in view 116, and extend along the length ofthe magnetic segment, e.g., in channels 114. The roller 104 may includeflex element supports such as to secure the U-brackets in a positionthat allows bias toward the assembled configuration. By interlocking theroller 104 with the magnets 103, the roller 104 and U-brackets 106 serveto provide structure and shape to the array while also strengthening andpreventing torsional motion in the array. This allows for more controlover the final placement of the magnetic compression anastomosis deviceand prevents an undesired geometry from forming.

Various profiles of various geometries of magnetic arrays are possiblewith the vertebrae 101 of the present invention, as is shown in FIG. 25. For example, the vertebra skin 102 can include smooth and/or patternedfeatures and can be configured with different outer geometries such asto accomplish different anastomosis goals. For example, geometry (a) hasconcave sides, geometry (b) has convex sides with notches, geometry (c)has pointed side protrusions that could assist with cutting tissue, andgeometry (d) has flat sides that could compress and necrose a largerarea of tissue. The vertebrae 101 can include other features such asvarious types of protrusions or recesses, e.g., to help secure thedevice 100 to tissue. All vertebrae could use the same geometry, ordifferent vertebrae could use different geometries.

It should be noted that, while the flex element 106 is encapsulatedunderneath the vertebra skin in the embodiments described above,alternative embodiments could place the flex element(s) 106 on theoutside of the vertebra skin.

It should be noted that, while two example flex elements 106 are shownand described herein, the present invention is not limited to these orto any particular flex element(s). For example, a flex element couldinclude a coil spring. In some embodiments, a spring (e.g., a coilspring or a torsion spring, could act as both the roller and the flexelement, for example, as depicted schematically in FIG. 26 .

It should be noted that, in certain embodiments, the device 100 can beprovided within a delivery device such as a catheter, endoscope,laparoscope, trocar, needle, or other delivery device and therefore thedelivery device in combination with the device 100 can be considered anembodiment of the invention.

Embodiments also can include methods of manufacturing the device 100such as by providing the various components (e.g., magnets, rollers,flex elements, and vertebra skins), positioning a roller and flexelement between two magnets and securing them as needed (e.g., securingthe flex element within magnet channels), and placing a vertebra skinover the magnet, roller, and flex element.

It should be noted that kits can be provided with magnets, rollers, flexelements, and different types of vertebra skins having differentconfigurations that can be used for different types of anastomosisprocedures such that different devices 100 can be prepared, e.g.,depending on the amount and type of pressure needed for a particularprocedure, the location of the procedure, and the size of theanastomosis to be created.

It should be noted that self-assembling magnetic anastomosis addressesseveral of the historical disadvantages of traditional anastomosis suchas allowing a surgical-quality anastomosis in a minimally-invasivefashion using devices that reproducibly re-assemble into a larger magnetstructure of a predetermined shape in vivo. The constraints imposed bythe described embodiments are designed to allow the devices toconsistently self-assemble into the correct shape upon deployment, whichgreatly reduces the risks of surgical complications due to misshapendevices or premature detachment and also reduces the risks associatedwith surgical access and ensure that the anastomosis is formed with thecorrect geometric attributes. Overall, this ensures the patency of theanastomosis.

Thus, as described herein, embodiments include flexible linear magneticdevices comprising linked magnetic multipole segments that, whenextruded from the end of a deployment channel or lumen, self-assemble toform a rigid, multipolar polygonal ring magnet (PRM; generally “magneticdevice”). The self-assembly is directed by the configuration of magnets,rollers, flex elements, and vertebra skins that is capable of returningto a pre-determined shape. Generally speaking, the physical and magneticstructure of the deployed magnetic devices is such that when twomagnetic devices approach one another, there is a rapidly strengtheningattractive magnetic interaction, which creates a coupling between themagnetic devices. In some instances, it is necessary to pre-align thecomplimentary devices, however, in other instances the devicesself-align by undergoing fast in-plane rotation with respect to oneanother, as discussed in detail below. As described in detail below,systems including the magnetic devices may include an endoscope havingsensors that allow the endoscope to sense the position of a matingmagnetic device or another endoscope that will deploy the mating device.

When deployed in adjacent tissues, for example adjacent organs ordifferent regions of the same organ, the coupled magnetic devices createa compressive ring that can be surgically opened, or allowed to form ananastomosis without further intervention. When paired devices are leftalone, the compressive force against the tissues collapse thevasculature and extrude fluids in the tissues, further reducing thedistance between the devices and increasing the magnetic attraction.With time, the coupled devices eventually couple completely and fallaway, leaving a formed anastomosis. This cascade begins when the devicesapproach within “capture range,” whereby their mutually-attractiveforces are sufficient to align the devices, trap the intervening tissue,and resist the natural pliancy of the tissues as well as the motion ofthe tissue under normal physiologic function.

Overall, the design specifications of the devices depend on the patientand the intended anastomosis. The design specifications may include:required capture range, desired effective inner and outer diameters ofthe deployed polygonal rings (e.g., as defined by the desiredanastomosis size and instrument passage), thickness of the targettissue, and the inner diameter of guiding channel and the smallestradius of curvature to which the guiding channel may be bent and throughwhich the magnets must pass. Once the design specifications are chosen,corresponding magnetic device designs can be determined, such aspolygon-side-count and length, and the maximum lateral dimensions of theflexible linear magnetic structure that will be deployed through thedelivery instrument.

Deployment of a device 100 is generally illustrated in FIG. 1 . Whenused with the techniques described herein, the devices allow for thedelivery of a larger magnetic structures than would otherwise bepossible via a small delivery conduit, such as in a standard endoscope,if the devices were deployed as a completed assembly. Larger magnetstructures, in turn, allow for the creation of larger anastomoses thatare more robust, and achieve greater surgical success. Because themagnetic devices are generally radiopaque and echogenic, the devicesgenerally can be positioned using fluoroscopy, direct visualization(trans-illumination or tissue indentation), and ultrasound, e.g.,endoscopic ultrasound. The devices can also be ornamented withradiopaque paint or other markers to help identify the polarity of thedevices during placement. In some embodiments, the devices can bepositioned by use of sensors located in proximity to the delivery lumenand able to sense the position of a mating device, e.g., using a Reedswitch or a Hall-effect sensor.

In general, as shown in FIG. 2A, a magnetic anastomosis procedureinvolves placing a first and a second magnetic structure adjacent totargeted tissues, thus causing the tissues to come together. Themagnetic devices are generally deployed so that that opposite poles ofthe magnets will attract and bring the tissues together. The two devicesmay both be deployed inside the body, or one may be deployed inside thebody and the other outside the body. Once the magnets have beendeployed, the tissues circumscribed by the magnetic structures can becut to provide an immediate anastomosis, as shown in FIG. 2B. In otherembodiments, the tissues circumscribed by the devices will be allowed tonecrose and degrade, providing an opening between the tissues. While thefigures and structures of the disclosure are primarily concerned withannular or polygonal structures, it is to be understood that thedelivery and construction techniques described herein can be used tomake a variety of deployable magnetic structures. For example,self-assembling magnets can re-assemble into a polygonal structure suchas a circle, ellipse, square, hexagon, octagon, decagon, or othergeometric structure creating a closed loop. The devices may additionallyinclude handles, suture loops, barbs, and protrusions, as needed toachieve the desired performance and to make delivery (and removal)easier.

As described with respect to the figures, a self-assembling magneticanastomosis device can be placed with a number of techniques, such asendoscopy, laparoscopy, or with a catheter (e.g., not with directvisualization, fluoro, etc.). Regardless of method of device delivery,it is important to note that the procedure for creating the anastomosiscan be terminated without perforation of tissue after confirmation ofmagnet coupling. As described previously, the compression anastomosisprocess can be allowed to proceed over the ensuing days, resulting inthe natural formation of an opening between the tissues. The fusedmagnets can either be allowed to expel naturally or the magnets can beretrieved in a follow-up surgical procedure. Alternatively, if immediatebypass is required, the tissues circumscribed by the magnets can be cutor perforated. Perforation can be accomplished with a variety oftechniques, such as cautery, microscalpel, or balloon dilation of tissuefollowing needle and guidewire access.

In some embodiments, the self-assembling magnetic devices are used tocreate a bypass in the gastrointestinal tract. Such bypasses can be usedfor the treatment of a cancerous obstruction, weight loss or bariatrics,or even treatment of diabetes and metabolic disease (i.e. metabolicsurgery). Such a bypass could be created endoscopically,laparoscopically, or a combination of both. FIG. 3 illustrates thevariety of gastrointestinal anastomotic targets that may be addressedwith the devices of the invention: stomach to small intestine (A),stomach to large intestine (E), small intestine to small intestine (C),small intestine to large intestine (B), and large intestine to largeintestine (D). In an endoscopic procedure, the self-assembling magneticdevices can be delivered using two simultaneous endoscopes, e.g., anupper endoscope or enteroscope residing in the upper small intestine,and a colonoscope residing in the lower small intestine, as shown inFIG. 4A. Alternatively, as shown in FIG. 4B, two simultaneous upperendoscopes (e.g., one residing in the stomach and the second in thesmall intestine) can be used to place the devices. In other embodiments,the self-assembling magnets can be delivered sequentially through thesame endoscope, which has been moved between a first deployment positionand a second deployment position. For example, in FIG. 4A, a singleper-oral endoscope could deliver and deploy one self-assembling magnetin the small intestine, withdraw, and then deploy the second reciprocalmagnet in the stomach. Again, magnet coupling could be confirmed usingfluoroscopy. FIG. 5 illustrates removal of a single endoscope afterplacement of two magnetic devices.

A variety of techniques can be used to detect the first deployedmagnetic device to assist placement of the second mating structure. Oncethe first device is deployed at the desired anastomotic location, thetwo deployed magnetic devices need to find one another's magnetic fieldso that they can mate and provide the compressional force needed toprompt formation of an anastomosis. Ideally, the devices can be roughlylocated within several cm of one another (e.g., using ultrasound), atwhich point the magnets should self-capture and self-align. Where thisis not possible, other techniques such as one of the followingtechniques can be used. A first location technique involves a directcontact method using two endoscopes. Here an endoscope's displacement inan adjacent lumen creates a displacement seen by another endoscope inthe adjacent lumen. The displacement identifies a potential intersectionpoint for an anastomosis location. For example, a magnetic deploymenttool (described below) will be deflected by the presence of a deployeddevice on the other side of a tissue wall.

The second location technique involves trans-illumination, whereby highintensity light from one endoscope is directed at the lumen wall of theproposed anastomosis site. Using this technique, another endoscope inthe adjacent lumen looks for the light, which diffuses through the lumenwall and projects onto the wall of the adjacent lumen. This lightrepresents the potential intersection anastomosis point. A cap or lenscan also be placed over the light emitting endoscope to furtherintensify and pinpoint the proposed intersection point. A similartechnique could use radio-wave- or ultrasound-transducers and receiversto collocate the endoscope tips. In some embodiments, a system mayinclude an endoscope having a sensor and a magnetic anastomosis devicefor deployment using the endoscope.

A third location technique involves magnetic sensing techniques todetermine the proximity of the deployed ring magnet in the adjacentlumen. By maximizing the magnetic field being sensed, the minimumdistance between the adjacent channels can be identified. The magneticsensor can be carried on a probe inserted down the working channel ofthe endoscope and utilize common magnetic sensing technology such as aHall Effect Sensor or Reed switch.

With trans-illumination and magnetic sensing, an additional accessorymay also assist with delivering magnetic devises to a preciseanastomosis site. A radially expanding ring structure can be deployedwith the endoscope or laparoscope that can press fit and seat itself onthe scope's outer diameter. The outer diameter of this expanding elementis sized to allow the deployed device to seat itself on this expandingelement (again likely a press fit). With this expanding element andmagnetic device radially seated about the endoscope axis, the endoscopecan be directed to the ideal anastomotic location through directcontact, trans-illumination, or magnetic sensing, and then the matingmagnet device released when the anastomosis site is identified.

In other embodiments, the self-assembling magnet devices could bedelivered using ultrasound guidance, e.g., endoscopic ultrasound. Forexample, using an echoendoscope in the stomach, a suitable smallintestine target could be identified. As shown in FIG. 6 , a deliveryneedle 600 (e.g., an aspiration needle) or catheter can be used toaccess to the small intestine target and deliver the self-assemblingmagnets into the small intestine lumen. The delivery can be guided withfluoroscopy or endoscopic ultrasound. Following self-assembly, thesesmall intestine magnets would couple with a second set of magnetsdeployed in the stomach. The two devices can be delivered with the sameneedle or with different needles. It is also possible to deliver thefirst device with an endoscope and the second device with a needle orvice versa.

In another embodiment, illustrated in FIG. 7 , a first anastomosis,created in an initial procedure, can be used to provide access for thecreation of a second anastomosis. This process could theoretically berepeated multiple times to create additional anastomoses. For example, agastrojejunal anastomosis (stomach to mid-small intestine) could serveas a conduit for the creation of a second, more distal gastrojejunalanastomosis. Ultimately, in this particular scenario, the stomach wouldhave several bypasses to the small intestine. Additionally, in someinstances, more anastomoses could be added to “titrate” to a specificclinical effect (e.g., lower glycosylated hemoglobin in type 2diabetes). In alternative embodiments, an anastomosis may be placed togive access for a different type of surgery, e.g., tumor removal.

In another embodiment of delivery, the self-assembling magnets could bedelivered laparoscopically through a surgical incision into the targetorgans (e.g., stomach and small intestine) and allowed to couple tocreate an anastomosis, as shown in FIG. 8 . Again, this procedure couldbe directed with fluoroscopy or ultrasound and the procedure can bepurely laparoscopic, or a combination of endoscopic and/or laparoscopicand/or needle procedures.

Gastrointestinal anastomoses can be used to address a number ofconditions. An anastomosis or series of anastomoses between the proximalbowel and distal bowel may be used for treatment of obesity andmetabolic conditions, such as Type II diabetes and dyslipidemia. Theprocedure can also be used to induce weight loss and to improvemetabolic profiles, e.g., lipid profiles. The bowel includes any segmentof the alimentary canal extending from the pyloric sphincter of thestomach to the anus. In some embodiments, an anastomosis is formed tobypass diseased, mal-formed, or dysfunctional tissues. In someembodiments, an anastomosis is formed to alter the “normal” digestiveprocess in an effort to diminish or prevent other diseases, such asdiabetes, hypertension, autoimmune, or musculoskeletal disease.

Using the self-assembling magnetic devices as discussed herein, it ispossible to create a side-to-side anastomosis that does not requireexclusion of the intermediate tissues, as is common withstate-of-the-art bariatric procedures. That is, using the devices of theinvention (or other means for creating an anastomosis) it is possible tocreate an alternate pathway that is a partial bypass for fluids (e.g.,gastric fluids) and nutrients (e.g., food), while at least a portion ofthe old pathway is maintained. This design allows the ratio of “normal”to “modified” digestion to be tuned based upon the goals of theprocedure. In other words, using the described procedure, a doctor canchoose the ratio of food/fluids shunted down the new (partial) bypassversus food/fluids shunted down the old pathway. In most instances, thefraction shunted down the bypass limb will drive the patient toward thedesired clinical endpoint (e.g., weight loss, improvement inglycosylated hemoglobin, improvement in lipid profile, etc.) Themechanism by which the endpoints are achieved may involve earlymacronutrient delivery to the ileum with stimulation of L-cells andincrease in GLP-1 production, for example. The mechanism may alsoinvolve loss of efficiency of nutrient absorption, especially glucose,thereby reducing blood glucose levels. At the same time, however, thefraction shunted down the old pathway protects against known metaboliccomplications that can be associated with bariatric surgery such asexcessive weight loss, malabsorptive diarrhea, electrolyte derangements,malnutrition, etc.

To achieve a desired ratio of bypass (e.g., re-routing food andsecretions to flow down the new pathway, say, 70% or 80% or 90% or 100%of the time), the size, location, and possibly number of anastomoseswill be important. For example, for a gastrojejunal anastomosis, it maybe critical to place the anastomosis in a dependent fashion to takeadvantage of the effects of gravity. Also, instead of a roundanastomosis, it may be better to create a long, oval-shaped anastomosisto maximize anastomotic size. Alternatively, multiple gastrojejunalanastomoses may be used to titrate to a certain clinical endpoint (e.g.,glycosylated hemoglobin in Type II diabetes). Most of the proceduresdescribed herein may be used to place one or more anastomoses, asneeded, to achieve the desired clinical endpoint. For example, the twoendoscope procedures illustrated in FIGS. 4A and 4B can be used tocreate a partial bypass of a portion of the bowel. Based upon thedesired ratio of bypassed and non-bypassed nutrients, the anastomosesshown in FIGS. 4A and 4B can be made larger, e.g., greater than 1 cm inopen diameter, or several smaller anastomoses can be placed to achievethe desired ratio.

The procedure is also adjustable. For example, a first anastomosis maybe formed and then, based upon clinical tests performed after theprocedure, one or more anastomoses can be added to improve the resultsof the clinical tests. Based upon later clinical results, it may benecessary to add yet another anastomosis. Alternatively, it is possibleto partially reverse the condition by closing one or more anastomosis.Because the partially bypassed tissues were not removed, they can returnto near normal functionality with the passage of greater amounts ofnutrients, etc. The anastomoses may be closed with clips, sutures,staples, etc. In other embodiments, a plug may be placed in one or moreanastomoses to limit the ratio of nutrients that traverse the “normal”pathway. Furthermore, it is possible to close an anastomosis in onelocation in the bowel and then place a new anastomosis at a differentlocation. Thus, is possible to generally and tunably create partialbypasses, or a series of partial bypasses, between portions of the bowelto achieve clinical endpoints, e.g., as described in FIG. 3 .

The described procedures may also be used with procedures that remove orblock the bypassed tissues, as is common with bariatric procedures. Forexample, a gastrojejunal anastomosis may be coupled with a pyloric plug(gastric obstruction) or another closure of the pylorus (e.g., suturedclosure) to shunt food completely down the new bypass. Such procedurescan be used, for example, to bypass tissue that is diseased, e.g.,because of cancer.

In another category of procedures, endoscopic ultrasound (EUS) can beused to facilitate guided transgastric or transduodenal access into thegallbladder for placement of a self-assembling magnetic anastomosisdevice. Once gallbladder access is obtained, various strategies can beemployed to maintain a patent portal between the stomach and thegallbladder or the duodenum and the gallbladder. In another embodiment,gallstones can be endoscopically retrieved and fluid drained. Forexample, using the described methods, an anastomosis can be createdbetween the gallbladder and the stomach. Once the gallbladder isaccessed in a transgastric or transduodenal fashion, the gallstones canbe removed. Furthermore, the gallbladder mucosa can be ablated using anynumber of modalities, including but not limited to argon plasmacoagulation (APC), photodynamic therapy (PDT), sclerosant (e.g.,ethanolamine or ethanol).

One strategy for creation of a portal is to deploy self-assemblingmagnets via an endoscopic needle under ultrasound guidance into thegallbladder and also into the stomach or duodenum. These magnets willmate and form a compression anastomosis or fistula. A second strategyfor creation of a portal is to deploy self-assembling magnets via anendoscopic needle 600 as shown in FIGS. 9A and 9B. While the coupledmagnetic assemblies are shown as octagons, the closed frame could takethe shape of any polygonal structure, e.g., a square, a circle, atriangle, hexagon, heptagon, nonagon, decagon, dodecagon, etc. One suchdevice would be deployed into the gallbladder, and the mating devicewould be deployed into the stomach or duodenum. In the same fashion asdiscussed above with respect to gastrointestinal deployment, the tissuecircumscribed by the two magnetic devices can be cut with cautery,microscalpel, needle-knife, or other deployable cutting mechanism. Inanother embodiment, the coupled tissues can be left to necrose and formthe anastomosis.

The devices need not be limited to forming holes, however. Otherstructures can be coupled to one or more mating magnetic devices tocreated additional functionality. For example, a stent could be deployedbetween tissues, such as the gallbladder and the stomach, as shown inFIG. 10 . Alternatively, the gallbladder magnet could be coupled to aballoon-based device that fills with air, fluid, magnetic pieces ormagnetic particles. Upon inflation, the balloon would serve as an anchorin the bile duct following placement. The balloon could also have anannular configuration to allow for immediate access after coupling withthe second magnet. See, e.g., FIG. 11 . Regardless of embodiment,however, it is critical to contain the original access pathway withinthe confines of the coupled magnets, i.e., not leaving a pathway for theescape of bile. Otherwise, the opening will allow bile leakage that canresult in peritonitis.

Another medical application for self-assembling magnets is directbiliary access. Currently, to achieve decompression for a malignantbiliary stricture, endoscopic retrograde cholangiopancreatography (ERCP)is performed. The biliary tract is accessed endoscopically through thepapilla in retrograde fashion and a stent is deployed across thestricture over a guidewire. These stents frequently require subsequentprocedures for exchange, clean-out, or placement of additionaloverlapping stents. The need for exchange and cleaning is required tocounteract the high rate of infection of the biliary tree (i.e.cholangitis) when using an ERCP procedure. Because of the high rate ofmorbidity, ERCP is typically limited to patients that have no otheroption to address pancreatic disease.

Using devices of the invention, however, it is possible to easily forman anastomosis between the bile duct (preferably the main bile duct) andeither the duodenum or the stomach (choledocho-gastric andcholedocho-duodenal anastomoses, respectively). This anastomosis ispermanent and typically does not require intervention if located apartfrom the diseased tissue. In an embodiment, a biliary magnetic device isdelivered directly into the bile duct under endoscopic ultrasoundguidance. As described below, the self-assembling magnetic device isextruded through a needle or catheter, whereupon it deploys in thecorrect configuration. Using fluoroscopy or ultrasound, it is thenpossible to confirm that the device has self-assembled and is in thecorrect location. In some embodiments, the magnetic device may betethered to the delivery needle or catheter by means of a detachablewire or suture to enable mechanical retraction until optimal positioningis confirmed.

In one embodiment, the magnetic device can be delivered endoscopicallyto the bile duct via wall of the duodenum, as shown in FIG. 12 . Inanother embodiment, the biliary magnet can be delivered in conventionalretrograde fashion through the ampulla into the bile duct, as shown inFIG. 13 . One benefit of retrograde delivery is that it avoids needlepunctures across tissue planes, as is the case with the deploymentmethod shown in FIG. 12 . Regardless of the method for delivering thebiliary magnets, however, a second magnetic device is required in eitherthe gastric (A) or duodenal (B) lumen, as shown in FIG. 14 . Typically,this decision is dependent upon the patient's anatomy (e.g., size of theduodenal lumen) and the location of the initial biliary magnet. Inscenarios based on endoscopic ultrasound needle delivery, the secondmagnetic device can be connected to the biliary magnet via theaforementioned detachable wire, and therefore extruded through the samedelivery needle/catheter. Alternatively, the second device can bepre-attached to the exterior of the endoscope and slid into position forcoupling after biliary magnet deployment. The latter procedure may bemore applicable to forward-viewing echoendoscopes but may be used withendoscopes, generally.

In another embodiment, the biliary magnet is a balloon-based device thatfills with air, fluid, magnetic pieces or magnetic particles, similar topreviously described with respect to gallbladder procedures. Uponinflation, the balloon would serve as an anchor in the bile ductfollowing placement. In an embodiment, the balloon could have an annularconfiguration to allow for immediate access after coupling with thesecond magnet. Additionally, like the gallbladder procedures describedabove, a biliary magnetic device can be used with a stent form-factor.In an embodiment, the stent has an internal biliary magnet and a hingedexternal magnet. The stent can be inserted in retrograde fashion throughthe ampulla into the bile duct. The hinged external magnet can then beswung around and coupled with the internal biliary magnet to form afistula between the bile duct and the duodenum, as shown in FIG. 15 .

The magnetic devices of the invention can also be used to treatpancreatic diseases. For example, the pancreatic duct requiresdecompression in certain disease states, such as chronic pancreatitis.Currently, extensive pancreatic duct decompression requires surgery(e.g., Peustow surgery in which the pancreas is filleted along the axisof the pancreatic duct and connected to a loop of small intestine forimproved pancreatic drainage). As an alternative to Peustow surgery,extensive pancreatic duct decompression can be accomplished via creationof a large magnetic compression anastomosis between the pancreatic ductand either the stomach or duodenum using a magnetic pancreatic catheter,as shown in FIG. 16 . The catheter can be magnetic along its entirelength or only at certain intervals. The catheter can be in the form ofa stent or straw. The pancreatic duct can be accessed using conventionalERCP methods (retrograde cannulation through the ampulla) or by directneedle access using endoscopic ultrasound (EUS). The magnetic pancreaticcatheter can be delivered into the pancreatic duct and coupled with asecond magnetic device in either the stomach or duodenum. As in thebiliary scenario described above, the magnetic pancreatic catheter couldbe hinged to the second magnetic device.

Self-assembling magnetic devices can also be used to access and drainfluid collections located adjacent to the gastrointestinal tract, asshown in FIG. 17 . For example, following a bout of pancreatitis,pancreatic fluid collections can form that require drainage. Whiledrainage can be accomplished using surgery or a percutaneous catheter,endoscopic drainage has been found to be more clinically andcost-effective, but can be complicated by bleeding, perforation, and/orinadequate drainage. As an alternative to surgical draining, magneticdevices of the invention can be delivered through a needle or sharpenedcatheter into the collection under endoscopic ultrasound (EUS) guidance,as shown in FIG. 17 . Following assembly, the first magnetic device iscoupled to the second magnetic device that has been placed in thegastrointestinal lumen (e.g. stomach). In order to speed removal afterdrainage, the first magnet may be tethered by a connecting wire aspreviously described. As described previously, the intervening tissuecan be cut using electrocautery or dilation followed by needle and wireaccess. Additional devices, such as magnetic coupling clamps can be usedto control blood flows to allow for “blood-less” endoscopic entry intothe collection.

Self-assembling magnets can also be used for urological applicationssuch as forming bypasses to treat an obstructed urogenital tract, asshown in FIG. 18 . For example, a magnetic anastomosis could be createdbetween the renal calyx and bowel (A), between the ureter and bowel (B),or between the bladder and bowel (C). Self-assembling magnetic devicesof the invention can be delivered into the urological tract using anendoscope, laparoscope, or needle, as described above. The reciprocalmagnetic device could be delivered into the gastrointestinal tract usingan endoscope, laparoscope, or needle as previously described. In otherembodiments, the devices can be used for reproductive procedures, suchas bypassing a portion of obstructed fallopian tube or bypassing avasectomy.

In yet another application, self-assembling magnetic devices can be usedto create vascular anastomoses or to treat cardiac conditions. Forexample, a magnetic anastomosis coupling can be formed between adjacentblood vessels with magnetic devices, as shown in FIG. 19 . In anembodiment, the self-assembling devices can be delivered with a vasculardelivery device, such as a catheter. Additionally, as described abovewith respect to gallbladder and pancreatic applications, a shunt can beinstalled to bypass a portion of the vasculature that is weak orblocked.

Self-assembling magnets can also be used for pulmonary applications suchas forming bypasses in the airway to treat chronic obstructive pulmonarydisease (COPD). For example, magnetic anastomoses can be created bydeploying self-assembling magnetic devices into adjacent bronchioles, asshown in FIG. 20 . Creation of pulmonary “bypasses” could lower airwayresistance that characterizes respiratory diseases such as COPD.

Self-assembling magnetic devices can also be used to create surgicalstomas for diversion of a fecal stream, e.g., into a colostomy bag. Forexample, a magnetic anastomosis can be created by deployingself-assembling magnets into the gastrointestinal tract (e.g. largeintestine), as shown in FIG. 21 , and then coupling the interior magnetto an external magnet worn and secured at the level of the skin. Theexterior magnetic device may be coupled to yet a third magnetic devicethat is coupled to a collection device. Such a system allows easyremoval of the collection device for cleaning, etc.

While various inventive embodiments have been described and illustratedherein, those of ordinary skill in the art will readily envision avariety of other means and/or structures for performing the functionand/or obtaining the results and/or one or more of the advantagesdescribed herein, and each of such variations and/or modifications isdeemed to be within the scope of the inventive embodiments describedherein. More generally, those skilled in the art will readily appreciatethat all parameters, dimensions, materials, and configurations describedherein are meant to be exemplary and that the actual parameters,dimensions, materials, and/or configurations will depend upon thespecific application or applications for which the inventive teachingsis/are used. Those skilled in the art will recognize, or be able toascertain using no more than routine experimentation, many equivalentsto the specific inventive embodiments described herein. It is,therefore, to be understood that the foregoing embodiments are presentedby way of example only and that, within the scope of the appended claimsand equivalents thereto, inventive embodiments may be practicedotherwise than as specifically described and claimed. Inventiveembodiments of the present disclosure are directed to each individualfeature, system, article, material, kit, and/or method described herein.In addition, any combination of two or more such features, systems,articles, materials, kits, and/or methods, if such features, systems,articles, materials, kits, and/or methods are not mutually inconsistent,is included within the inventive scope of the present disclosure.

Various inventive concepts may be embodied as one or more methods, ofwhich examples have been provided. The acts performed as part of themethod may be ordered in any suitable way. Accordingly, embodiments maybe constructed in which acts are performed in an order different thanillustrated, which may include performing some acts simultaneously, eventhough shown as sequential acts in illustrative embodiments.

All definitions, as defined and used herein, should be understood tocontrol over dictionary definitions, definitions in documentsincorporated by reference, and/or ordinary meanings of the definedterms.

The indefinite articles “a” and “an,” as used herein in thespecification and in the claims, unless clearly indicated to thecontrary, should be understood to mean “at least one.”

The phrase “and/or,” as used herein in the specification and in theclaims, should be understood to mean “either or both” of the elements soconjoined, i.e., elements that are conjunctively present in some casesand disjunctively present in other cases. Multiple elements listed with“and/or” should be construed in the same fashion, i.e., “one or more” ofthe elements so conjoined. Other elements may optionally be presentother than the elements specifically identified by the “and/or” clause,whether related or unrelated to those elements specifically identified.Thus, as a non-limiting example, a reference to “A and/or B”, when usedin conjunction with open-ended language such as “comprising” can refer,in one embodiment, to A only (optionally including elements other thanB); in another embodiment, to B only (optionally including elementsother than A); in yet another embodiment, to both A and B (optionallyincluding other elements); etc.

As used herein in the specification and in the claims, “or” should beunderstood to have the same meaning as “and/or” as defined above. Forexample, when separating items in a list, “or” or “and/or” shall beinterpreted as being inclusive, i.e., the inclusion of at least one, butalso including more than one, of a number or list of elements, and,optionally, additional unlisted items. Only terms clearly indicated tothe contrary, such as “only one of” or “exactly one of,” or, when usedin the claims, “consisting of,” will refer to the inclusion of exactlyone element of a number or list of elements. In general, the term “or”as used herein shall only be interpreted as indicating exclusivealternatives (i.e., “one or the other but not both”) when preceded byterms of exclusivity, such as “either,” “one of,” “only one of,” or“exactly one of.” “Consisting essentially of,” when used in the claims,shall have its ordinary meaning as used in the field of patent law.

As used herein in the specification and in the claims, the phrase “atleast one,” in reference to a list of one or more elements, should beunderstood to mean at least one element selected from any one or more ofthe elements in the list of elements, but not necessarily including atleast one of each and every element specifically listed within the listof elements and not excluding any combinations of elements in the listof elements. This definition also allows that elements may optionally bepresent other than the elements specifically identified within the listof elements to which the phrase “at least one” refers, whether relatedor unrelated to those elements specifically identified. Thus, as anon-limiting example, “at least one of A and B” (or, equivalently, “atleast one of A or B,” or, equivalently “at least one of A and/or B”) canrefer, in one embodiment, to at least one, optionally including morethan one, A, with no B present (and optionally including elements otherthan B); in another embodiment, to at least one, optionally includingmore than one, B, with no A present (and optionally including elementsother than A); in yet another embodiment, to at least one, optionallyincluding more than one, A, and at least one, optionally including morethan one, B (and optionally including other elements); etc.

As used herein in the specification and in the claims, all transitionalphrases such as “comprising,” “including,” “carrying,” “having,”“containing,” “involving,” “holding,” “composed of,” and the like are tobe understood to be open-ended, i.e., to mean including but not limitedto. Only the transitional phrases “consisting of” and “consistingessentially of” shall be closed or semi-closed transitional phrases,respectively, as set forth in the United States Patent Office Manual ofPatent Examining Procedures, Section 2111.03.

Various embodiments of the present invention may be characterized by thepotential claims listed in the paragraphs following this paragraph (andbefore the actual claims provided at the end of the application). Thesepotential claims form a part of the written description of theapplication. Accordingly, subject matter of the following potentialclaims may be presented as actual claims in later proceedings involvingthis application or any application claiming priority based on thisapplication. Inclusion of such potential claims should not be construedto mean that the actual claims do not cover the subject matter of thepotential claims. Thus, a decision to not present these potential claimsin later proceedings should not be construed as a donation of thesubject matter to the public. Nor are these potential claims intended tolimit various pursued claims.

Without limitation, potential subject matter that may be claimed(prefaced with the letter “P” so as to avoid confusion with the actualclaims presented below) includes:

P1. Individual magnetic vertebrae sections for a magnetic compressionanastomosis device comprising: a vertebrae skin comprising a metalalloy, polymer, and/or composite material; a flex segment configured asa tensile member; a sprung flex member configured to aid in formation ofan array; a roller configured to provide radial constraint and limitdegrees of freedom to strengthen the array from a torsional standpoint.

P2. The vertebrae of claim P1 further comprising: a roller or nodeconfigured to create rotation in one plane while limiting torsionaldegrees of freedom 90 degrees opposing; and stops configured to limitone or more degrees of freedom.

P3. The vertebrae of claim P1 further comprising: a male node of a firstvertebra configured to interlock with a female node of a second vertebrawherein the vertebrae are shaped to provide interference allowing aprescribed amount of rotation around an axis of the male node and femalenode.

Although the above discussion discloses various exemplary embodiments ofthe invention, it should be apparent that those skilled in the art canmake various modifications that will achieve some of the advantages ofthe invention without departing from the true scope of the invention.Any references to the “invention” are intended to refer to exemplaryembodiments of the invention and should not be construed to refer to allembodiments of the invention unless the context otherwise requires. Thedescribed embodiments are to be considered in all respects only asillustrative and not restrictive.

What is claimed is:
 1. A magnetic compression anastomosis devicecomprising: a plurality of interconnected vertebrae including a firstvertebra and a second vertebra, wherein each of the first vertebra andthe second vertebra is a multipiece vertebra comprising a magnet atleast partially encapsulated by a vertebra skin, and wherein the firstvertebra and the second vertebra are interconnected by a cylindricalroller and at least one flex element, the roller and the at least oneflex element at least partially encapsulated by the first vertebra skinand the second vertebra skin, the roller configured to allow the firstand second vertebra to pivot through a predetermined range of rotationin a device plane between at least a delivery configuration and anassembled configuration while constraining movement in other degrees offreedom, the at least one flex element biasing the first and secondvertebra toward the assembled configuration.
 2. The device of claim 1,wherein the vertebra skin comprises at least one of a metal alloy, apolymer, or a composite material.
 3. The device of claim 1, wherein thevertebra skin comprises a shape memory material.
 4. The device of claim1, wherein the vertebra skin is configured with at least one tissuecutting element.
 5. The device of claim 1, wherein the vertebra skin isconfigured with at least one tissue compression element.
 6. The deviceof claim 1, wherein the vertebra skin is configured with at least onetissue securing element.
 7. The device of claim 1, wherein each vertebraskin includes male nodes and female nodes at opposing ends of thevertebra skin.
 8. The device of claim 7, wherein the male nodes areconfigured to secure the roller in place.
 9. The device of claim 1,wherein the roller is a hollow cylinder.
 10. The device of claim 1,wherein the roller is a solid cylinder.
 11. The device of claim 1,wherein the flex element comprises a flexible bar.
 12. The device ofclaim 11, wherein the flexible bar comprises a spring mechanism.
 13. Thedevice of claim 12, wherein the spring mechanism comprises a shapememory material.
 14. The device of claim 1, wherein the flex elementcomprises a pair of U-brackets operationally coupled to the roller. 15.The device of claim 1, wherein the roller and the flex element areimplemented using a coil or torsion spring.
 16. The device of claim 1,wherein the vertebrae are aligned in a substantially linear arrangementin the delivery configuration.
 17. The device of claim 1, wherein thevertebrae are arranged in a circular arrangement in the assembledconfiguration.
 18. The device of claim 1, wherein the vertebrae arearranged in a polygon arrangement in the assembled configuration. 19.The device of claim 1, wherein the vertebrae include a proximal endvertebra and a distal end vertebra that magnetically couple to oneanother in the assembled configuration.
 20. A magnetic compressionanastomosis system comprising: a delivery device comprising a lumen; andat least one magnetic compression anastomosis device according to claim1 predisposed within the lumen of the delivery device in the deliveryconfiguration.